CONSENT
Most investigators obtain consent through personal discussion. This method is highly recommended, since it
allows specific questions to be answered.
There are three practical reasons for a written consent form:
A written
consent form is usually required by regulatory agencies.
The
consent form can aid the investigator in discussing the study with
the subject by providing a checklist of
items.
The
consent form can help the subject to recall the discussion with
the investigator.
Should a subject have difficulty recalling any aspect of the
discussion, a clear and understandable form--left with the subject--may help
resolve the confusion, refresh the memory, and encourage compliance.
Enclosed is a packet of information which we hope will help you
prepare the consent form for your research study. It contains:
List of
Required Elements of Informed Consent
Required
Elements of Informed Consent, with examples
Example
of Abbreviated Consent Form for Minimal Risk Studies
Example
of Consent Form for a Greater than Minimal Risk study.
It is acceptable for you to design a consent form in your own personal
style so long as all of the required elements are included. You must also include the "Patient
Representative" statement if the subjects are hospital patients.
I will be glad to answer questions, provide clarification on
requirements or definitions, or assist in preparing consent forms. I encourage you to call on me for guidance in
preparing consent forms for studies involving children and/or incompetent
subjects; special considerations must be made.
Please feel free to call me at
Bobette K. Godding
Manager, Office of Research Subjects
LIST
OF REQUIRED ELEMENTS OF INFORMED CONSENT
1.
An invitation
to participate.
2.
A statement of
the general purpose of the study.
3.
The procedures
to be followed. Identify any procedures that are experimental.
4.
Discomforts
and inconveniences. This includes length
of time involved, additional trips to the clinic which wouldn't be required for
clinical purposes, etc.
5.
Risks. Include risks which a person would want to know
about; which this medical community would inform the patient; which are
relatively frequent; which are relatively serious. Consider physical risks, but
also legal, economic, and psychological risks.
6.
Benefits to
the subject.
7.
Standard
treatment to be withheld or alternative procedures that are available.
8.
Costs to the
subject as a result of participation or compensation that may be offered to pay
for expenses, time, inconvenience, but not as an inducement to assume risk.
9.
For studies
involving greater than minimal risk include availability of treatment and/or compensation
in the event of a research-related injury.
10.
Confidentiality. If this is a study monitored by the FDA, include
the possibility of FDA access to medical/study records. Include any other agency, which could have
access, e.g., State Health Department, sponsoring agency, pharmaceutical
company.
11.
Offer to
answer questions. Include name and
telephone number of investigator as well as the statement on the availability
of the Patient Representative.
12.
Voluntary
nature of participation. Include that
refusal to participate or withdrawal from the study will not affect the
subject's relationship with
13.
Statement that
the subject will be given a copy of the consent form. (May be unsigned.)
14.
Signature of
research subject and person obtaining consent.
Additional Elements When Appropriate
a)
A statement
that the treatment or procedure may involve risks to the subject (or embryo or
fetus) which are currently unforeseeable.
b)
Anticipated
circumstances under which the subjects participation maybe terminated without
regard to the subject's consent.
c)
The
consequences of a subject's decision to withdraw from the study, and procedures
for the orderly termination of participation.
d)
A statement
that significant new findings developed during the course of the study which
may relate to the subject's willingness to continue participation will be
provided.
e)
The
approximate number of subjects in the study.
f)
Additional
elements are required in research involving children, incompetent subjects,
pregnant women, fetuses, prisoners, etc.
Please contact the IRB office at
There Are
Required Elements of Informed Consent With Examples
It is strongly suggested that the consent forms be separated into
sections, with boldface or capitalized headings. This is particularly important when consent
forms are long.
1. Invitation
To Participate:
Example:
You are invited to participate in a research study.
2. Purpose/Introduction: What is
being studied? Why? Why you?
Who are the investigators? This
section should set the stage and provide a quick overview.
Examples:
A study is being
done by D. Jones, M.D. and R. Smith, Ph.D., to learn more about a cause of
(condition), the disease you have. You
are invited to be in the study.
XX is currently the standard treatment for (disease). It is known that
a percentage of people have not responded to XX. Since you have not responded to XX, you are
invited to be in a study of an experimental treatment for this disease.
3. Procedures: What, if anything, will happen
to you if you participate? How long will
it take? The explanation should not include procedures that are
part of standard care. Procedures that
are different from or in addition to standard care must be included. They
should be described in terms of subject experience, e.g., blood drawing, rather
than laboratory tests (
Examples:
If you agree to participate, you will return to the clinic for 10
additional monthly visits of one hour each.
At each visit you will have the following tests that are not for your treatment
or diagnosis...
If you agree to participate you will be interviewed for one hour. The questions will concern your background
and how you feel about the treatment your family has received in the
clinic. The interview will take place in
your home and, if you agree, it will be tape recorded.
If you agree to be in the study you will be randomly assigned to one
of two groups. This means you will have
an equal chance of being in either group.
Neither your doctor nor you will make the decision. The two groups are:
A. Group A will have the standard dosage for 6
weeks instead of the usual 3 weeks.
B. Group B will have the usual treatment time but at twice the usual
dosage.
4&5 Risks/Discomforts/Inconveniences:
Subjects should be able to gain a fair idea of the risks that they are
taking and of the discomforts or inconveniences they might experience as a
result of consenting. These include not
only physical risks, but also potential legal, economic, or psychological risks
that are relevant. A general rule of
thumb is that any side effect that is "relatively" frequent or that
is "relatively" serious or permanent should be included. Any side effect, e.g., sterility, scarring,
should be mentioned.
Examples:
This drug may cause an allergic reaction such as skin rashes or
hives. It can cause a rare,
penicillin-like, allergic reaction that could be life-threatening.
You may be assigned to a group that is later shown to have more side
effects or be a less effective treatment.
This information will not be known until the study data is analyzed.
Taking blood from a vein may cause discomfort or bruising at the site.
A small amount of heparin, an anti-clotting medication, is used with
the temporary needle. You may experience
discomfort, bleeding, bruising or infection at the needle site. Blood will be drawn X times from the
temporary needle and then the needle will be removed at the end of the X
hours. A total of about XXccs (XX
teaspoons) of blood will be drawn.
The interview will take approximately two hours of your time. You may regard some of these questions as
sensitive and private. You do not have
to answer any question that makes you feel uncomfortable. Your name will not appear in any published
information. Confidentiality will be
protected.
As part of this study you will have (kinds and numbers of x-ray or
isotope procedures). The total
radiation you will receive will be (fraction) of the limit recommended
by the FDA for research in humans receiving radiation. The amount is low enough that it is very
unlikely to be dangerous, although the lasting effects of small amounts of
radiation in humans are unknown. Much
larger doses cause cancer and birth defects in humans.
If pregnant women and/or nursing mothers are to be EXCLUDED
from the study, the following statement should be included:
If it is possible that you could be pregnant, or if you are
breastfeeding, you must not participate
in this study.
If women of childbearing years are to be INCLUDED in a greater
than minimal risk study, the following statements should be considered and if
appropriate included:
If you are a woman and are pregnant or breastfeeding you must not
participate in this study. If you are a
woman of childbearing years, a pregnancy test will be done to assure that you
are not pregnant. You must use a reliable
form of contraceptive while participating in this study. If you should become pregnant at any time during
the study, you must notify your doctor.
6. Benefits: An unbiased
statement should be included. It should
not be overstated or read like an advertisement.
Examples:
There will be no direct benefit to you from participating. The investigators hope to learn more about X
and Y, which may help treat patients like you more effectively in the future.
The additional tests to be done are not needed for treatment or your
diagnosis. The information put in your medical record may be of interest to
your personal physician.
Information from recent research suggests that this procedure of
antibiotic administration may be more effective in eliminating your
infection. By using this new procedure
you will not require an I.V. for six weeks.
NOTE: MONEY
PAID TO SUBJECTS OR
7. Standard Treatment Withheld Or
Alternatives Available: This section must describe the options open
if the subject refuses participation.
Standard treatment withheld must be stated here. If the only alternative is simple refusal,
e.g., to throw away a questionnaire, this section may be omitted.
Examples:
Instead of participating in the study, you and your doctor may make
the decision. Thetreatments available are drugs A, B or C.
If you choose not to participate in this study, standard therapy/alternative
therapy/other alternative procedures will be available to you. (Describe)
8. Costs And Compensation: Make a
clear statement about any additional costs to the patient. Compensation/payment
is to be offered only to pay for expenses, time, or inconvenience. Payment is
not for inducing people to assume any risk. The IRB encourages investigators to
discuss costs with them.
Examples:
Those laboratory tests not directly required for your care will be
provided at no cost to you.
If the pacemaker must be changed for any reason, a replacement unit
will be provided by the sponsor at no cost to you. However, payment for the medical care related
to the implantation of the unit, such as surgery, physician services,
hospitalization, medication, etc., must be made by you or your third party
payer (insurance, Medicare, etc.).
You will be given $10.00 for each visit plus an added $5.00 whenever
blood is drawn, for a total of $65.00.
You will receive an additional $15.00 for completing all the visits.
9. Treatment For Research-Related Injury: Do not
forget to include the statement on treatment and compensation for harm if there
is any real or foreseeable risk of physical harm.
Examples:
If you are injured as a result of being in this study, medical
treatment will be available to you. The costs of such treatment will be paid
for by XYZ Pharmaceutical Company.
If you perceive any harmful effects or symptoms as a result of being
in this study, medical treatment will be available to you. The cost of such treatment must be paid by
you or your third party payer (insurance, Medicare, etc.).
10. Confidentiality:
Examples:
All information collected as part of this study which can be identified
with you will be kept confidential and will be released only with your written
permission.
Only the investigator, the sponsor (XYZ Pharmaceutical Corp.) and,
under certain circumstances, the U.S. Food and Drug Administration will be able
to review and/or obtain data which identifies you by name.
11. Questions: Few
patients are able to comprehend the study immediately. It is important to offer a 24 hour number for
the investigator in the event of delayed effects or questions. If the investigator is at REGIONS HOSPITAL/RC
part-time, include the name and number of a full-time REGIONS HOSPITAL/RC staff
member who is knowledgeable about the study.
The Patient Representative statement must be used when
Example:
If you have questions, please ask them now. If you have any additional questions later,
you may reach Dr. Jones at
You must use the following statement
if the subjects are patients at
As is the case for all patients of
12. Voluntary
Participation:
Example:
Participation in research is voluntary. You have the right to refuse to participate
and the right to withdraw later without affecting (your present or future
treatment at the
13. Copy
Of Consent Form:
Example:
You will be given a copy of this consent form to keep.
14. Signatures:
I have had a chance to ask questions about the
study including the risks of harmful effects that might occur as described in
this consent form. Based on this
information, I willingly agree to participate in the study.
___________________________ ______________
Signature of Subject Date
I, the investigator, certify that to the best of my
knowledge, the patient/participant/person responsible signing this consent form
has had the study fully explained and clearly understands the nature, risks,
and any benefits of participating in this research project.
___________________________ ______________
Signature of Investigator Date
If
appropriate for the specific study:
I, as the relative/person responsible for the
research subject, have had a chance to ask questions about the study including
the risks of harmful effects that might occur as described in this consent
form. Based on this information, I
willingly agree to allow the patient/my relative to participate in the study.
___________________________ ______________
Signature of Person Responsible Date
Example Of Abbreviated Consent
Form For Minimal Risk Study
Consent To Be A Research Subject
Dr. Jones is doing a study to learn more about anemia. To do this she needs to collect a small
amount of blood from healthy people and from people with anemia.
If you agree to participate, a trained technician will remove ( tsp.) of blood from your arm vein.
Having the blood drawn may be somewhat uncomfortable and may produce a
bruise at the site.
The study may produce information of use to patients in the future,
but there will be no direct benefit to you.
If you have any questions, please ask them now. If you have any additional questions later,
you may reach Dr. Jones at
You will be given $X.00 for each donation of blood. The laboratory tests required for this study
will be provided at no cost to you.
Any information collected as part of this study that can be identified
with you will be kept confidential. You
will be given a copy of this consent form to keep.
Your participation in research is voluntary. You have the right to refuse to participate
or to later withdraw from the study without affecting (your care at this
I have had a chance to ask questions about the
study including the risks of harmful effects that might occur as described in
this consent form. Based on this information,
I willingly agree to participate in the study.
All verbal information and discussions about the study have been in a
language I speak, write and read easily.
___________________________ ______________
Signature of Subject Date
I, the investigator, certify that to the best of my
knowledge, the patient/participant/person responsible signing this consent form
has had the study fully explained and clearly understands the nature, risks,
and any benefits of participating in this research project.
___________________________ ______________
Signature of Investigator Date
If
appropriate for the specific study:
I, as the relative/person responsible for the research
subject, have had a chance to ask questions about the study including the risks
of harmful effects that might occur as described in this consent form. Based on this information, I willingly agree
to allow the patient/my relative to participate in the study. All verbal information and discussions about
the study have been in a language I speak, write and read easily.
___________________________ ______________
Signature of Person Responsible Date
Example Consent Form For Greater
Than Minimal Risk Study
Consent To Be A Research Subject
Dr. X and Dr. Y are doing a research study to learn more about the
relationship between the way the surface of the stomach looks through an
endoscope, on an x-ray and in a tissue specimen. Since you have already been scheduled to have
an endoscopic examination for your care, we would like to invite you to be a
subject in this study.
Procedures
If you agree to be in the study the following will occur: During your endoscopy a blue dye (methylene
blue) will be sprayed on the surface of your stomach, through the
endoscope. A maximum of 3 small pieces
of your stomach lining (biopsies) will be taken through the endoscope. Color photographs of your stomach lining with
the blue dye on it will be taken through the endoscope. These additional
procedures will extend your endoscopy by about 5 minutes. The endoscopy ordinarily takes X minutes.
Risks/Discomfort
Participation in this study may mean some added risk or
discomfort. A small amount of bleeding
may occur after the biopsies. This
should stop by itself in a little while.
In 1 in 1000 cases bleeding continues and may require transfusion. Your urine might turn bluish for a day. This is normal after use of methylene blue
and there is no need for concern.
Benefits
There will be no benefit to you from these procedures, but physicians
may learn more about the tests used to evaluate the stomach lining.
Alternatives To
Participating
If you choose to not take part in the study, your endoscopic
examination will be performed in the usual way, without the biopsies or
photographs.
Costs
There will be no additional charges to you if you do participate in
the study.
Research Related
Injury
If you are injured as a result of being in this study, treatment will
be available. The costs of such
treatment must be paid by you or your third party payer (insurance, Medicare,
etc.).
OR
The costs of such treatment will be paid by the sponsor of this study.
Confidentiality
All information obtained in connection with the study that can be
identified with you will remain confidential and will be released only with
your written permission.
Questions:
Dr. X has talked with you about this study and has answered your
questions. If you have other questions
you may call him at
Voluntary
Participation
Participation in research is voluntary. You may refuse to participate or you may
withdraw at any time without affecting the treatment you receive at the
You will be given a copy of this consent form to keep.
I have read and understand the preceding information. I have had an opportunity to ask questions
and all my questions have been answered to my satisfaction. I understand that by signing this form I am
agreeing to participate in this study. I
may withdraw from this study at any time without affecting my present or future
care at
Signature of patient/person responsible and Date
relationship
Signature of person obtaining consent Date
Elements of Informed Consent:
Requirements and Guidelines for Consent Forms:
Informed consent is
the process of communicating to the
subject the purpose, risks, benefits, and voluntary nature of a specific study.
The consent form documents that the communication
process took place. The consent form
must contain all of the required "elements" of informed consent. The "sample consent form" should be
used as a guide for writing a consent form.
The consent form should be written in lay terms; jargon and technical
language should be avoided. The IRB
recommends that researchers write the consent forms using simple declarative
sentences, avoid technical language.
Tips for completing consent form: